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Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive

on the Wiley Online Library


Panel members at the time of adoption

F. Aguilar, U.R. Charrondiere, B. Dusemund, P. Galtier, J. Gilbert, D.M. Gott, S. Grilli,
R. Guertler, J. Koenig, C. Lambré, J-C. Larsen, J-C. Leblanc, A. Mortensen, D. Parent-Massin, I. Pratt, I.M.C.M. Rietjens, I. Stankovic, P. Tobback, T. Verguieva, R.A. Woutersen.


The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Ponceau 4R (E 124). Ponceau 4R has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1983 and the EU Scientific Committee for Food (SCF) in 1984. Both
committees established an Acceptable Daily Intake (ADI) of 0-4 mg/kg bw/day. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. Relevant new studies included a study by Tsuda et al. from 2001 reporting effects on nuclear DNA migration in the mouse in vivo Comet assay, a study by Tanaka from 2006 on neurobehavioural effects and a study by McCann et al. from 2007 that concluded that exposure to a mixture including Ponceau 4R resulted in increased hyperactivity in 3-year old children. The Panel notes that Ponceau 4R was negative in in vitro genotoxicity as well as in long term carcinogenicity studies and that the effects on nuclear DNA migration are not expected to result in carcinogenicity. The Panel also concurs with the conclusion from a previous EFSA opinion on the McCann et al. study that the findings of the study cannot be used as a basis for altering the ADI. The Panel also re-evaluated a long-term mouse study reporting glomerulonephrosis from which they derived a No-Observed-Adverse-Effect Level of 70 mg/kg bw/day. Based on these findings the Panel derives an ADI of 0.7 mg/kg bw/day. The Panel concludes that at the maximum levels of use, intake estimates for adults at the high percentile (97.5th) and for 1- to 10-year old children at the mean and the high percentiles (95th/97.5th) are generally above the ADI even in the refined intake estimates.